Chronic Hypertension and Pregnancy (CHAP) Project
CHAP
A Pragmatic Multicenter Randomized Clinical Trial (RCT) of Antihypertensive Therapy for Mild Chronic Hypertension During Pregnancy: Chronic Hypertension and Pregnancy (CHAP) Project
2 other identifiers
interventional
2,408
1 country
72
Brief Summary
The purpose of this study is to evaluate whether a blood pressure treatment strategy during pregnancy to achieve targets that are recommended for non-pregnant reproductive-age adults (\<140/90 mmHg) compared ACOG- recommended standard during pregnancy (no treatment unless BP is severe) is effective and safe.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 hypertension
Started Jun 2015
Longer than P75 for phase_4 hypertension
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2014
CompletedFirst Posted
Study publicly available on registry
November 24, 2014
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2022
CompletedResults Posted
Study results publicly available
May 17, 2023
CompletedMay 17, 2023
May 1, 2023
6.8 years
October 28, 2014
April 4, 2023
May 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Composite Adverse Perinatal Outcome
One or more severe outcomes including fetal death or neonatal death up to discharge or 90 days if prior; preeclampsia with severe features up to 2 weeks postpartum (Severe hypertension and proteinuria or hypertension and severe features per ACOG); placental abruption; or indicated PTB \<35 weeks (not due to spontaneous preterm labor or membrane rupture).
Up to 2 weeks postpartum for preeclampsia or 90 days for neonatal death
Small for Gestational Age (Safety)
Birth weight less than 10th percentile for gestational age at birth according to accepted national standard
Until delivery
Secondary Outcomes (5)
Composite of Maternal Death or Severe Cardiovascular Morbidity
Up to 6 weeks (4-12 weeks) after delivery
Severe Maternal Hypertension + Components of the Primary Composite Endpoint
Up to 2 weeks postpartum or 90 days for neonatal death
Preterm Birth and Indicated Preterm Birth (<37 Weeks)
Until delivery
Composite of Severe Neonatal Morbidities
Up to 90 days post delivery
Adherence to Treatment After Delivery
6 weeks (4-12 weeks) after delivery
Other Outcomes (26)
Superimposed Preeclampsia
Up to 2 weeks after delivery
Superimposed Gestational Hypertension
Enrollment (between 6 and 18 weeks gestation) to delivery
Severe Hypertension
Up to 6 weeks (4-12 weeks) after delivery
- +23 more other outcomes
Study Arms (2)
Anti-hypertensive therapy to goal <140/90 mmHg
EXPERIMENTALLabetalol or Nifedipine ER will be used as first-line to achieve goal; if necessary Nifedipine ER or Labetalol will be second-line antihypertensive. Rarely, other antihypertensive medications may also be used
No anti-hypertensive unless BP is severe (≥160/105 mmHg
ACTIVE COMPARATORAntihypertensive therapy given only if BP becomes severe (defined as BP ≥160/105). The lowest dose of anti-hypertensive needed to keep blood pressure below this threshold will be given (1st-line - Labetalol or Nifedipine ER and 2nd-line - Labetalol or Nifedipine ER). Rarely other medications may be used
Interventions
1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
Treatment will not be started if blood pressure remains \<160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
Eligibility Criteria
You may qualify if:
- Women with chronic hypertension in pregnancy with new or untreated chronic hypertension, blood pressure 140-159 systolic or 90-104 diastolic OR known chronic hypertension on monotherapy and taking any antihypertensive and blood pressure ≤159/104 (including those with blood pressure \<140/90);
- Singleton; and
- viable pregnancy \<23 weeks of gestation.
You may not qualify if:
- Blood pressures prior to randomization ≥160 systolic or ≥105 diastolic (with or without treatment);
- Severe hypertension including patients currently treated with \>1 antihypertensive medication (more likely to have severe chronic hypertension);
- Multi-fetal pregnancy;
- Known secondary cause of chronic hypertension;
- High-risk co-morbidities for which treatment may be indicated:
- Diabetes mellitus diagnosed at age ≤10 years or duration of diagnosis ≥20 years
- Diabetes mellitus complicated by end organ damage (retinopathy, nephropathy, heart disease, transplant)
- Chronic kidney disease - including baseline proteinuria (\>300mg/24-hr, protein/creatinine ratio ≥0.3, or persistent 1+ proteinuria\*) or creatinine \>1.2.
- \*If a dipstick value at screening is more than trace, a clean catch or catheter urine should be obtained and re-tested by dipstick. If this shows trace or absence of protein, the patient is included. If it again shows 1+ protein, the patient is excluded until a 24-hr urine \<300mg/24hr or p/c ratio is \<0.3. If a p/c ratio is \>0.3, the patient may be included if a 24-hour urine is \< 300 mg.
- Cardiac disorders: cardiomyopathy, angina, CAD
- Prior stroke
- Retinopathy
- Sickle cell disease
- Known major fetal anomaly;
- Known fetal demise;
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- Columbia Universitycollaborator
- Drexel University College of Medicinecollaborator
- Rutgers, The State University of New Jerseycollaborator
- Lehigh Valley Hospitalcollaborator
- Saint Peters University Hospitalcollaborator
- Christiana Care Health Servicescollaborator
- Washington University School of Medicinecollaborator
- Duke Universitycollaborator
- University of Texas Southwestern Medical Centercollaborator
- The University of Texas Health Science Center, Houstoncollaborator
- Stanford Universitycollaborator
- University of Pennsylvaniacollaborator
- The University of Texas Medical Branch, Galvestoncollaborator
- University of Utahcollaborator
- Intermountain Health Care, Inc.collaborator
- University of California, San Franciscocollaborator
- Johns Hopkins Universitycollaborator
- University of Pittsburghcollaborator
- Ochsner Health Systemcollaborator
- University of North Carolina, Chapel Hillcollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
- WakeMed Health and Hospitalscollaborator
- San Francisco General Hospitalcollaborator
- McKay-Dee Hospitalcollaborator
- Winthrop University Hospitalcollaborator
- New York Hospital Queenscollaborator
- Latter Day Saints Hospitalcollaborator
- Lyndon B Johnson General Hospitalcollaborator
- Virtua Medical Groupcollaborator
- Duke Regional Hospitalcollaborator
- Utah Valley Regional Medical Centercollaborator
- Northwestern Universitycollaborator
- Women and Infants Hospital of Rhode Islandcollaborator
- Baylor College of Medicinecollaborator
- Case Western/Metro Healthcollaborator
- Ohio State Universitycollaborator
- University of Iowacollaborator
- University of California, San Diegocollaborator
- Indiana Universitycollaborator
- Meriter Foundationcollaborator
- Weill Medical College of Cornell Universitycollaborator
- University of Oklahomacollaborator
- Medical University of South Carolinacollaborator
- Beaumont Hospitalcollaborator
- University of Colorado, Denvercollaborator
- University of Kansas Medical Centercollaborator
- Denver Health and Hospital Authoritycollaborator
- Gundersen Health Systemcollaborator
- Wake Forest University Health Sciencescollaborator
- Oregon Health and Science Universitycollaborator
- Medical College of Wisconsincollaborator
- Temple Universitycollaborator
- New Jersey Medical Schoolcollaborator
- University of South Alabamacollaborator
- Vanderbilt Universitycollaborator
- University of Arkansascollaborator
- Emory Universitycollaborator
- St. Luke's Hospital and Health Network, Pennsylvaniacollaborator
- The Cleveland Cliniccollaborator
- University of Tennesseecollaborator
- TriHealth Inc.collaborator
- Tulane Universitycollaborator
- Yale Universitycollaborator
- Arrowhead Regional Medical Centercollaborator
- Geisinger Cliniccollaborator
- Miami Valley Hospitalcollaborator
Study Sites (72)
University of Alabama at Birmingham, Clinical Coordinating Center
Birmingham, Alabama, 35294, United States
University of Alabama at Birmingham, Data Coordinating Center
Birmingham, Alabama, 35294, United States
University of South Alabama
Mobile, Alabama, 36604, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Arrowhead Regional Medical Center
Colton, California, 92324, United States
University of California, San Diego
San Diego, California, 92110, United States
General Hospital of San Francisco
San Francisco, California, 94110, United States
University of California San Francisco
San Francisco, California, 94143, United States
Stanford University
Stanford, California, 94305, United States
University of Colorado
Boulder, Colorado, 80204, United States
Denver Health
Denver, Colorado, 80204, United States
Yale University
New Haven, Connecticut, 06511, United States
Christiana Care Health Services
Newark, Delaware, 19713, United States
University of South Florida
Tampa, Florida, 33606, United States
Emory University
Atlanta, Georgia, 30322, United States
Northwestern
Evanston, Illinois, 60208, United States
Indiana University
Bloomington, Indiana, 47405, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Kansas Medical Center
Lawrence, Kansas, 66045, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Tulane
New Orleans, Louisiana, 70112, United States
Ochsner Health System/Medical Center
New Orleans, Louisiana, 70115, United States
Beaumont Hospital
Royal Oak, Michigan, 48073, United States
University of Mississippi Medical College
Jackson, Mississippi, 39216, United States
Washington University
St Louis, Missouri, 63110, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
St. Peters University Hospital
New Brunswick, New Jersey, 08901, United States
New Jersey Medical School
Newark, New Jersey, 07103, United States
Virtua Medical Group
Sewell, New Jersey, 08080, United States
New York Presbyterian Queens
Flushing, New York, 11355, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Columbia University
New York, New York, 10032, United States
Weill Cornell
New York, New York, 10065, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke Regional Medical Center
Durham, North Carolina, 27704, United States
Duke University
Durham, North Carolina, 27705, United States
WakeMed
Raleigh, North Carolina, 27610, United States
TriHealth, Inc
Cincinnati, Ohio, 45220, United States
Case Western/Metro Health
Cleveland, Ohio, 44109, United States
Cleveland Clinic Fairview
Cleveland, Ohio, 44111, United States
Ohio State University
Columbus, Ohio, 43210, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Cleveland Clinic-Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Lehigh Valley Hospital/Health Network
Allentown, Pennsylvania, 18101, United States
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015, United States
Geisinger Clinic
Danville, Pennsylvania, 17822, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19019, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19104, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
University of Pittsburg/Magee Women's Center
Pittsburgh, Pennsylvania, 15201, United States
Brown (WIHRI)
Providence, Rhode Island, 02912, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Tennessee Health Science Center
Memphis, Tennessee, 38103, United States
Vanderbilt University
Nashville, Tennessee, 37232, United States
UT Southwestern
Dallas, Texas, 75390, United States
UT Medical Branch
Galveston, Texas, 77555, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
UT Houston
Houston, Texas, 77030, United States
McKay Dee Hospital
Ogden, Utah, 84403, United States
Utah Valley Regional Medical Center
Provo, Utah, 84604, United States
Intermountain Healthcare
Salt Lake City, Utah, 84132, United States
University of Utah
Salt Lake City, Utah, 84132, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Gundersen Health System
La Crosse, Wisconsin, 54601, United States
Unity Point Health-Meriter Hospital
Madison, Wisconsin, 53715, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Aurora Research Institute
Milwaukee, Wisconsin, 53233, United States
Related Publications (5)
Sanusi AA, Leach J, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson KS, Haas DM, Plante L, Metz TD, Casey B, Esplin S, Longo S, Hoffman MK, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Su EJ, Krishna I, Nguyen NA, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Galis ZS, Harper L, Ambalavanan N, Geller NL, Kuo HC, Sinkey RG, Librizzi R, Pereira L, Magann EF, Habli M, Williams S, Mari G, Pridjian G, McKenna DS, Parrish M, Eugene Chang, Osmundson S, Quinones J, Szychowski JM, Tita ATN. Pregnancy Outcomes of Nifedipine Compared With Labetalol for Oral Treatment of Mild Chronic Hypertension. Obstet Gynecol. 2024 Jul 1;144(1):126-134. doi: 10.1097/AOG.0000000000005613. Epub 2024 May 23.
PMID: 38949541DERIVEDMoore MD, Kuo HC, Sinkey RG, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson KS, Haas DM, Plante L, Metz TD, Casey B, Esplin S, Longo S, Hoffman MK, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey HA, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Kinzler W, Su EJ, Krishna I, Nguyen NA, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Librizzi R, Pereira L, Magann EF, Habli M, Williams S, Mari G, Pridjian G, McKenna DS, Parrish M, Chang E, Osmundson S, Quinones JN, Leach J, Sanusi A, Galis ZS, Harper L, Ambalavanan N, Szychowski JM, Tita ATN. Mean Arterial Pressure and Neonatal Outcomes in Pregnancies Complicated by Mild Chronic Hypertension. Obstet Gynecol. 2024 Jul 1;144(1):101-108. doi: 10.1097/AOG.0000000000005611. Epub 2024 May 23.
PMID: 38781591DERIVEDBailey EJ, Tita ATN, Leach J, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson K, Haas DM, Plante L, Metz TD, Casey BM, Esplin S, Longo S, Hoffman M, Saade GR, Foroutan J, Tuuli MG, Owens MY, Simhan HN, Frey HA, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Kinzler W, Su EJ, Krishna I, Nguyen N, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Galis ZS, Harper L, Ambalavanan N, Oparil S, Kuo HC, Szychowski JM, Hoppe K. Perinatal Outcomes Associated With Management of Stage 1 Hypertension. Obstet Gynecol. 2023 Dec 1;142(6):1395-1404. doi: 10.1097/AOG.0000000000005410. Epub 2023 Sep 28.
PMID: 37769314DERIVEDGoulding AN, Antoniewicz L, Leach JM, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Edwards RK, Gibson K, Haas DM, Plante L, Metz TD, Casey B, Esplin S, Longo S, Hoffman M, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, Reddy UM, Kinzler W, Su E, Krishna I, Nguyen N, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Harper LM, Ambalavanan N, Oparil S, Szychowski JM, Tita AT; Chronic Hypertension and Pregnancy Trial Consortium. Breastfeeding initiation and duration among people with mild chronic hypertension: a secondary analysis of the Chronic Hypertension and Pregnancy trial. Am J Obstet Gynecol MFM. 2023 Sep;5(9):101086. doi: 10.1016/j.ajogmf.2023.101086. Epub 2023 Jul 10.
PMID: 37437694DERIVEDTita AT, Szychowski JM, Boggess K, Dugoff L, Sibai B, Lawrence K, Hughes BL, Bell J, Aagaard K, Edwards RK, Gibson K, Haas DM, Plante L, Metz T, Casey B, Esplin S, Longo S, Hoffman M, Saade GR, Hoppe KK, Foroutan J, Tuuli M, Owens MY, Simhan HN, Frey H, Rosen T, Palatnik A, Baker S, August P, Reddy UM, Kinzler W, Su E, Krishna I, Nguyen N, Norton ME, Skupski D, El-Sayed YY, Ogunyemi D, Galis ZS, Harper L, Ambalavanan N, Geller NL, Oparil S, Cutter GR, Andrews WW; Chronic Hypertension and Pregnancy (CHAP) Trial Consortium. Treatment for Mild Chronic Hypertension during Pregnancy. N Engl J Med. 2022 May 12;386(19):1781-1792. doi: 10.1056/NEJMoa2201295. Epub 2022 Apr 2.
PMID: 35363951DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Alan Tita
- Organization
- University of Alabama at Birmingham
Study Officials
- PRINCIPAL INVESTIGATOR
Alan Tita, MD, PhD
University of Alabama at Birmingham - Clinical Coordinating Center
- PRINCIPAL INVESTIGATOR
Gary Cutter, PhD
University of Alabama at Birmingham-Data Coordinating Center
- PRINCIPAL INVESTIGATOR
Jeff Szychowski, PhD
University of Alabama at Birmingham-Data Coordinating Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 28, 2014
First Posted
November 24, 2014
Study Start
June 1, 2015
Primary Completion
April 1, 2022
Study Completion
December 16, 2022
Last Updated
May 17, 2023
Results First Posted
May 17, 2023
Record last verified: 2023-05